Record of Telephone Conversation, October 19, 2012 - Flublok
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 19-Oct-2012 01:07 PM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
2. Information Request
Author: TIMOTHY FRITZ
Pregnancy registry comments/requests.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, October 19, 2012 1:07 PM
To: 'Penny Post'
Subject: CBER Information Request STN 125285
Dear Dr. Post-
Our review of your Flublok BLA submission (STN 125285) is ongoing. We have reviewed your September 21, 2012, submission (Amendment 62) and have the following comments and requests for information:
1. The proposal for a pregnancy registry states that the Patient Information Sheet will include contact information “for women to report pregnancies within 2 months of receipt of FluBlok.” Please clarify whether, in addition to including pregnancies that begin within 2 months following FluBlok vaccination, PSC plans to include all pregnancies during which FluBlok vaccination occurs. For example, if someone is vaccinated in the 7th month of pregnancy, will that person be included? Also, please clarify whether vaccine recipients must report pregnancies within 2 months of vaccination or whether pregnancy reporting is permitted if more than 2 months have elapsed since vaccination.
2. The proposal mentions only fetal/infant outcomes. Please consider also evaluating medical conditions in pregnant women (e.g., eclampsia, pre-term labor, placenta abruptio, etc.).
3. Please clarify whether the “Annual Report for FluBlok” is the same as the Periodic Safety Update Report (or Periodic Adverse Event Report), or is a document specifically for pregnancy outcomes.
Please provide your response as an Amendment to STN 125285. In your reply, we recommend that you restate our request and follow it with your explanation or
clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.
If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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